TIDMMPH
RNS Number : 7632Z
Mereo BioPharma Group plc
14 January 2020
THIS ANNOUNCEMENT CONTAINS INSIDE INFORMATION AS DEFINED UNDER
THE MARKET ABUSE REGULATION (EU) NO. 596/2014. UPON PUBLICATION OF
THIS ANNOUNCEMENT THIS INFORMATION IS NOW CONSIDERED IN THE PUBLIC
DOMAIN.
Mereo BioPharma Announces Additional Positive Data from Phase 2b
ASTEROID Study of Setrusumab in Adults with Osteogenesis Imperfecta
and Provides Update on Regulatory Progress
Additional Data Demonstrate Dose-Dependent Increase in Bone
Strength Stiffness and Failure Load at the Radius as Measured by
Finite Element Analysis, a Second Prespecified Primary Endpoint,
Reaching Statistical Significance in High Dose Cohort
Statistically Significant Increase in Trabecular Bone Score at
the Lumbar Spine in Both Medium and High Dose Cohorts
EMA Supports Initiation of Planned Pivotal Pediatric Study; FDA
Type B End-of-Phase 2 Meeting Scheduled for Q1 2020
London and Redwood City, Calif., January 14, 2020 - Mereo
BioPharma Group plc (NASDAQ: MREO, AIM: MPH), "Mereo" or the
"Company," today announced additional endpoint data from the
Company's Phase 2b dose-ranging "ASTEROID" clinical study of
setrusumab (BPS-804), an anti-sclerostin antibody, in adults with
Type I, III or IV osteogenesis imperfecta ("OI"). These additional
prespecified endpoint data build upon the Company's 12-month
topline data from the ASTEROID study announced in November 2019,
which demonstrated a dose-dependent, statistically significant bone
building effect of setrusumab at multiple anatomical sites in adult
OI patients (irrespective of OI subtype). OI is a rare disorder
characterized by fragile bones and reduced bone mass with no
approved treatments.
"Based upon our review of the comprehensive data set from the
Phase 2b ASTEROID study, these additional prespecified analyses
support our previous conclusions that setrusumab is building bone
at the lumbar spine and is increasing bone strength at multiple
peripheral sites in adult OI patients," said Dr. Alastair
MacKinnon, Chief Medical Officer of Mereo. "We believe these
additional endpoint data, together with the totality of the
12-month topline data and trend in fracture rate reduction in the
high dose cohort, are fully supportive of moving forward with our
planned pivotal trial in children with OI. To this end, we have
made additional progress on the regulatory front, including a
positive recent meeting with the European Medicines Agency ("EMA"),
and are currently preparing for a Type B End-of-Phase 2 meeting
with the FDA, scheduled for the first quarter of 2020."
"Finite element analysis ("FEA") is one of the best measures
available to monitor bone strength in clinical studies, being
sensitive to important changes in trabecular and cortical bone as
well as overall bone structure. In OI patients given setrusumab for
12 months, the FEA technique was used to assess forearm (radius)
bone strength at the beginning and end of the treatment period,"
said Dr. Ken Poole, Reader in Metabolic Bone Disease at the
University of Cambridge. "These new data are consistent with an
effect of setrusumab at the high dose on improving radius bone
strength as evidenced by a better ability to resist experimental
deformation and improved failure load. There are no currently
approved therapies for osteogenesis imperfecta, and treatment
options are greatly needed."
Additional Prespecified Efficacy Endpoint Results
Finite Element Analysis to Measure Bone Strength by Failure Load
and Stiffness at the Radius (Second Primary Endpoint on a
Hierarchical Basis)
The primary endpoint of the ASTEROID study was change in
Trabecular Volumetric Bone Mineral Density (Tr. vBMD) of the radius
(wrist) over baseline after 12 months of treatment as measured by
High Resolution peripheral Quantitative Computed Tomography
(HR-pQCT), followed by bone strength as calculated using FEA, a
derived measurement of the mechanical strength gained by
accumulated material in the bone.
Setrusumab demonstrated a dose dependent increase in both
failure load and stiffness at the radius at 12 months, achieving
statistical significance in the high dose cohort across both of
these parameters (p=0.037 for failure load and p=0.022 for
stiffness). FEA is based on the totality of the bone compartments
(trabecular and cortical bone) and these data demonstrate that
treatment with high dose setrusumab results in a significant
increase in bone strength at the peripheral bone sites, consistent
with the previously reported statistically significant increases in
total vBMD as measured by HRpQCT (a secondary endpoint of the
study).
Table 1: Increase in Failure Load at the radius determined by
FEA and by dose cohort (all OI subtypes)
Dose Cohort Mean % Change in Failure Load P value at 12 months
at 12 months
High (n=27) +2.0% p<0.037
------------------------------ ---------------------
Medium (n=20) +1.1% NS
------------------------------ ---------------------
Low (n=22) -0.06% NS
------------------------------ ---------------------
Table 2: Increase in stiffness at the radius determined by FEA
and by dose cohort (all OI subtypes)
Dose Cohort Mean % Change in Stiffness P value at 12 months
at 12 months
High (n=27) +2.2% P<0.022
--------------------------- ---------------------
Medium (n=20) +1.0% NS
--------------------------- ---------------------
Low (n=20) +0.1% NS
--------------------------- ---------------------
Trabecular Bone Score at the Lumbar Spine (Prespecified
Exploratory Secondary Endpoint)
Trabecular bone score (TBS) is a gray-level texture index
determined from patient lumbar spine dual-energy X-ray
absorptiometry (DXA) scans that correlates with 3D parameters of
trabecular bone architecture thought to help predict fracture. DXA
is a well-established measurement tool of bone mineral density
(cortical + trabecular bone).
Setrusumab demonstrated a statistically significant increase in
TBS at both the high (p<0.001) and medium dose cohorts
(p<0.001). Importantly, the spine is composed of both trabecular
and cortical bone and these data demonstrate efficacy of setrusumab
in the trabecular bone compartment at the lumbar spine which can be
combined with the previously reported data from HRpQCT at the
radius showing the impact of setrusumab on the cortical bone.
Table 3: Increase in TBS at the vertebral spine (all OI
subtypes)
Dose Cohort Mean % Change in Stiffness P value at 12 months
at 12 months
High (n=27) 3.7% P<0.001
--------------------------- ---------------------
Medium (n=20) 3.2% P<0.001
--------------------------- ---------------------
Low (n=22) -0.47% NS
--------------------------- ---------------------
As previously reported, topline 12-month safety results suggest
setrusumab was safe and well tolerated in the ASTEROID study.
Regulatory Progress Update
As part of the PRIME pathway, Mereo has discussed the results of
the Phase 2b ASTEROID study with the EMA. On the basis of the Phase
2b data, the EMA supports the initiation of the planned pivotal
pediatric study in Europe on the basis of the previously approved
pediatric investigational plan (PIP). This is based on a primary
endpoint of fracture rate over a 12-month period in approximately
165 children aged 5 to <18 years old.
Mereo expects to conduct a Type B End-of-Phase 2 meeting with
the U.S. Food and Drug Administration (FDA) in Q1 2020 to discuss
the data from the Phase 2b ASTEROID study as well as the proposed
pediatric pivotal study design. Mereo intends to announce the
outcome of these discussions following the meeting.
About the Phase 2b ASTEROID Study
ASTEROID was a 12-month, randomized, double-blind, Phase 2b
dose-finding study in 112 adults diagnosed with type I, III or IV
Osteogenesis Imperfecta and a confirmed COL1A1/COL1A2 mutation who
have fractured over the previous 5 years. ASTEROID was the largest,
prospectively-designed, interventional clinical study to be
performed in this patient group. The primary endpoint of the study
was the change over baseline in Tr vBMD of the wrist at 12 months,
followed by bone strength measured by Finite Element Analysts
(hierarchical) assessed using HR-pQCT. Change from baseline at 6
and 12 months for areal BMD at the lumbar spine, as measured by
DXA, was an important secondary endpoint. Additional secondary
endpoints included HR-pQCT parameters (such as total vBMD), bone
biomarkers, patient reported outcomes (PRO) and quality of life
measures. Fracture data were also collected throughout the duration
of the study, although the trial was not statistically powered for
fractures.
About Osteogenesis Imperfecta
Osteogenesis Imperfects (OI) is a rare genetic disorder that is
characterized by fragile bones and reduced bone mass resulting in
bones that break easily, loose joints and weakened teeth. In severe
cases patients may experience hundreds of fractures in a lifetime.
In addition, people with OI often suffer muscle weakness, early
hearing loss, fatigue, curved bones, scoliosis, respiratory
problems and short stature, leading to significant impacts on
overall health and quality of life. The majority of cases of OI
(estimated at approximately 90%) are caused by a dominant mutation
in a gene coding for type I collagen, a key component of healthy
bone. Current treatment of OI is supportive, focusing on minimizing
fractures and maximizing mobility, but to date, there are no EMA or
FDA approved treatments.
About Setrusumab
Setrusumab is a fully humanized monoclonal antibody that
inhibits sclerostin, a protein which inhibits the activity of
bone-forming cells. The mechanism of action of setrusumab could be
particularly well suited for the treatment of OI and has the
potential to become the first approved treatment option that could
reduce fractures and improve OI patients' quality of life. In
addition to evaluating setrusumab in adult OI patients, Mereo's
Paediatric Investigation Plan (PIP) has been approved by the
European Medicines Agency (EMA) and a study design has been agreed
for a pivotal registration trial in children, based on a primary
endpoint of fracture rate over a 12-month period. The pivotal study
will be conducted in approximately 165 children aged 5 to <18
years old with OI, initially in EU and Canada. Mereo continues to
review the optimum ratio of potential partnering and equity income
to finance the pivotal programme for setrusumab.
Mereo has obtained orphan drug designation in OI for setrusumab
in both the United States and the EU, in February 2017 setrusumab
was accepted into the EMA's adaptive pathways program in the EU
and, in November 2017 it was accepted into the EMA's Priority
Medicines scheme (PRIME).
About Mereo BioPharma
Mereo BioPharma is a biopharmaceutical company focused on the
development and commercialization of innovative therapeutics that
aim to improve outcomes for patients with rare diseases. Mereo's
strategy is to selectively acquire product candidates for rare
diseases that have already received significant investment from
pharmaceutical and large biotechnology companies and that have
substantial preclinical, clinical and manufacturing data packages.
Mereo's lead rare disease product candidate, setrusumab, has
completed a Phase 2b dose ranging study in adult patients with
osteogenesis imperfecta ("OI"). Mereo's second lead product
candidate, alvelestat, is being investigated in a Phase 2
proof-of-concept clinical trial in patients with alpha-1
antitrypsin deficiency ("AATD") with topline data expected in
mid-2020.
Mereo's broader pipeline consists of four additional
clinical-stage product candidates; acumapimod for the treatment of
acute exacerbations of chronic obstructive pulmonary disease
("AECOPD"), leflutrozole for the treatment of hypogonadotropic
hypogonadism ("HH") in obese men, navicixizumab for the treatment
of platinum-resistant ovarian cancer (recently licensed to
Oncologie), and etigilimab for patients with advanced or metastatic
solid tumors.
Forward-Looking Statements
This document contains "forward-looking statements." All
statements other than statements of historical fact contained in
this presentation are forward-looking statements within the meaning
of Section 27A of the United States Securities Act of 1933, as
amended (the "Securities Act"), and Section 21E of the United
States Securities Exchange Act of 1934, as amended (the "Exchange
Act"). Forward-looking statements usually relate to future events
and anticipated revenues, earnings, cash flows or other aspects of
our operations or operating results. Forward-looking statements are
often identified by the words "believe," "expect," "anticipate,"
"plan," "intend," "foresee," "should," "would," "could," "may,"
"estimate," "outlook" and similar expressions, including the
negative thereof. The absence of these words, however, does not
mean that the statements are not forward-looking. These
forward-looking statements are based on the Company's current
expectations, beliefs and assumptions concerning future
developments and business conditions and their potential effect on
the Company. While management believes that these forward-looking
statements are reasonable as and when made, there can be no
assurance that future developments affecting the Company will be
those that it anticipates.
Factors that could cause actual results to differ materially
from those in the forward-looking statements include risks relating
to unanticipated costs, liabilities or delays; failure or delays in
research and development programs, including expected timing of
topline data for the Phase 2 proof-of-concept clinical trial
evaluating the Company's second lead product candidate, alvelestat,
in patients with alpha-1 antitrypsin deficiency; the safety and
efficacy of the Company's product candidates and the likelihood of
clinical data to be positive and of such product candidates to be
approved by the applicable regulatory authorities; unanticipated
changes relating to competitive factors in the Company's industry;
risks relating to the Company's capitalization, resources and
ownership structure, including as a result of circumstances
affecting the Company's former principal shareholder; the
availability of sufficient resources for company operations and to
conduct or continue planned clinical development programs,
including the Company's ability to continue as a going concern;
changes in law or regulations affecting the Company.
All of the Company's forward-looking statements involve risks
and uncertainties (some of which are significant or beyond its
control) and assumptions that could cause actual results to differ
materially from the Company's historical experience and its present
expectations or projections. The foregoing factors and the other
risks and uncertainties that affect the Company's business,
including those described in its Annual Report on Form 20-F,
Reports on Form 6-K and other documents filed from time to time by
the Company with the United States Securities and Exchange
Commission (the "SEC") and those described in other documents the
Company may publish from time to time should be carefully
considered. The Company wishes to caution you not to place undue
reliance on any forward-looking statements, which speak only as of
the date hereof. The Company undertakes no obligation to publicly
update or revise any of our forward-looking statements after the
date they are made, whether as a result of new information, future
events or otherwise, except to the extent required by law.
Mereo BioPharma Contacts:
Mereo +44 (0)333 023 7300
Denise Scots-Knight, Chief Executive Officer
Richard Jones, Chief Financial Officer
Cantor Fitzgerald Europe (Nominated Adviser
and Broker to Mereo) +44 (0)20 7894 7000
Phil Davies
Will Goode
Burns McClellan (US Public Relations Adviser
to Mereo)
+01 (0) 212 213
Lisa Burns 0006
Steve Klass
FTI Consulting (UK Public Relations Adviser
to Mereo)
Simon Conway
Ciara Martin +44 (0)20 3727 1000
Investors:
investors@mereobiopharma.com
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END
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